With this inspection, the FDA confirmed that Oasmia’s manufacturing facility with respect to Paccal® Vet (paclitaxel) meets the requirements of Current Good Manufacturing Practice (cGMP).
“This is a significant milestone in our endeavours to bring our products to the market, and we are very pleased that the FDA has confirmed Oasmia’s cGMP manufacturing capability and commitment to provide products of high quality”, said Julian Aleksov, CEO of Oasmia Pharmaceutical AB.
Notes to editors:
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics, which, in comparison with current alternatives, show improved properties, reduced side effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ OMX Stockholm (OASM) and the Frankfurt Stock Exchange (OMAX, ISIN SE0000722365).
cGMP (Current Good Manufacturing Practice) is a regulatory framework enforced by the FDA with requirements as to how a medicinal product must be manufactured, so as to be eligible for FDA marketing authorization. Whether these requirements are met is determined by an FDA review that may include on-site inspections and other evaluation measures. For additional information see: www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm.